The FDA released a final interchangeability guidance that regulators hope will help speed cheaper biosimilars to patients who need them desperately.
The agency says sponsors probably won’t have to conduct separate clinical trials to prove that their biosimilars are interchangeable with “brand” biosimilars, but it does urge makers to conduct switching studies to help understand the risks of using their product versus the already-approved drug.
The Association for Accessible Medicines said it “applauds” the final guidance document, “particularly its streamlined data and study design requirements that allow flexibility and the use of global comparator products to support applications.”
